Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors - Full Text View

Purpose

This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.

Condition	Intervention	Phase
Cancer Survivor Prevention of Human Papillomavirus Infection	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) Other: laboratory biomarker analysis Other: survey administration Other: medical chart review	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ] [ Designated as safety issue: No ]
To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
Safety/tolerability of the HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 7-14 days following last vaccine dose ] [ Designated as safety issue: Yes ]
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population


Estimated Enrollment:	1268
Study Start Date:	July 2012
Estimated Primary Completion Date:	January 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Prevention (vaccine therapy) Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) Given IM Other Names: Gardasil Gardasil 9 Other: laboratory biomarker analysis Correlative studies Other: survey administration Ancillary studies Other: medical chart review Ancillary studies Other Name: chart review

Detailed Description:

PRIMARY OBJECTIVES:

I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.

II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.

III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.

OUTLINE:

AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.

AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Eligibility


Ages Eligible for Study:	9 Years to 26 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

AIM 1 (SURVEY) (AIM 1 is closed to enrollment)
Cancer survivor
Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant [HCT])
Scheduled for a return clinic visit at one of the participating institutions
English or Spanish-speaking
Willing to provide informed consent/assent for study participation
AIM 2 (VACCINE EVALUATION)
Meets all inclusion criteria outlined in Aim 1
Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report
English or Spanish-speaking
Medical clearance from treating clinician for study participation
Agrees to return to participating institution for 3 HPV vaccine injections
Willing to provide informed consent/assent for study participation

Exclusion Criteria:

AIM 2 (VACCINE EVALUATION)
Allergy to any component of the HPV vaccine including yeast and aluminum
Thrombocytopenia (platelet count < 50K) or coagulation disorder that would contraindicate intramuscular injection
Transfusion of blood products or intravenous immune globulin within 3 months of study entry
Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492582

Locations


United States, Alabama
University of Alabama at Birmingham	Recruiting
Birmingham, Alabama, United States, 35233
Contact: Wendy Landier, PhD, CRNP 205-638-2120 wlandier@peds.uab.edu
Principal Investigator: Wendy Landier, PhD, CRNP
United States, California
City of Hope Medical Center	Active, not recruiting
Duarte, California, United States, 91010
United States, Georgia
Emory University School Of Medicine	Active, not recruiting
Atlanta, Georgia, United States, 30308
United States, Michigan
University of Michigan	Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, Tennessee
Saint Jude Children's Research Hospital	Active, not recruiting
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

University of Alabama at Birmingham

National Cancer Institute (NCI)

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	Wendy Landier, PhD, CRNP	University of Alabama at Birmingham

More Information


Responsible Party:	Wendy Landier, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01492582 History of Changes
Other Study ID Numbers:	UAB-F141204009/UAB-X141204010 NCI-2011-03654 1R01CA166559 Merck-IISP#40083 COH-11034
Study First Received:	December 12, 2011
Last Updated:	April 22, 2016
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:


Infection Papillomavirus Infections DNA Virus Infections Virus Diseases	Tumor Virus Infections Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016